Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product...
FDA Recall #D-0651-2024 — Class II — August 22, 2024
Product Description
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
ProRx LLC — Exton, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
37 vials
Distribution
Nationwide in the USA
Code Information
Lot # ProRx040924-1, BUD 10/08/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated